CLASS II ONGOING Device recall · Reported 24 Nov 2021 · FDA Enforcement Report
Quantum 2000 Electrosurgical Generators Cooper Surgical recalled
CooperSurgical is recalling Quantum 2000 Electrosurgical Generators Cooper Surgical, distributed nationwide in the US. The recall was initiated on 29 Sep 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0261-2022
- FDA event ID
- 88648
- Recalling firm
- CooperSurgical, Trumbull, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Sep 2021
- FDA classified
- 18 Nov 2021
- Reported
- 24 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 29 Sep 2021 | Recall initiated by company | |
| 18 Nov 2021 | Classified by FDA | +50 days |
| 24 Nov 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
Where it was distributed
US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM
Questions about this recall
Why was it recalled?
Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
Which lots are affected?
Serial Numbers: 0112010 0209001 0214002 0309031 0313007BFIX 0411002 0609010FIX 0710001 0711008 0713011C 0809009 0813032CFIX 091402 1013009C 1013015C 1109017 1214005 2015090019 2015110003 2016030001 2016040012 2016060016 2016090003 2016110002 2017010005 2017060010 2017080010 QTMAA-4-095 QTM-AB-10-149 QTM-M-4-102FIX W110954 W351106 W60413 0114011 0212004 0214007 0312021 0313010B 0413003B 0612001B 0710003 0711008FIX 0713018C 0811017 0813033C 1011010 1013010C 1014004 1111002 2015040009 2015090021 2015110004 2016030002 2016040015 2016060020 2016090004 2016110003 2017020004 2017060013 AFZFIX QTMAA4101 QTM-AB-12-164 QTMY-11-0201 W204996 W381180 W605041 0114013 0212008 0214008 0312024 0313011B 0511002 0612003B 0710008 0711009 0714007 0811021 0813034C 1011010FIX 1013011C 1109008 1213005C 2015060003 2015100004 2015110009 2016040001 2016040018 2016070003 2016090007 2016110004 2017030002 2017080002 ATM-AA-4-106 QTMAA-4-102 QTM-AB-12-165 QTMY-12-0208 W2A1022 W381192 W708311FIX 0115006 0212010 0215005 0312033 0409005 0511003 0612010B 0710008FIX 0712009B 0809004 0811021FIX 0814011FIX 1012006B 1013012C 1109014 1213006C 2015090012 2015100006FIX 2015110010 2016040002 2016060012 2016070007 2016090014 2016120002 2017030005 2017080003 GHILL QTMAA6116 QTMAB3067 QTMY70139 W2B1036 W604009 0115007 0214001 0215007 0313001B 0409006 0511003FIX 0612016B 0711006 0713001C 0809007 0813029C 0814012 1013006C 1013014C 1109015 1214003 2015090015 2015110001 2016020006 2016040007 2016060013 2016080002 2016110001 2017010002 2017030009 2017080006 IUY80207 QTMAA-6-116 QTM-AB-9135 W107893 W2C1054 W604013
Where was it sold?
US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 88648| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Leep Precision Integrated System recalled by CooperSurgical | CooperSurgical | Device Malfunction | Nationwide | |
| CLASS II | Quantum 2000 Electrosurgical Generators Cooper Surgical recalled | CooperSurgical | Other | Nationwide | |
| CLASS II | Leep Precision Generator 220V Cooper Surgical recalled | CooperSurgical | Device Malfunction | Nationwide | |
| CLASS II | Leep Precision Integrated System, 120V CooperSurgical recalled | CooperSurgical | Device Malfunction | Nationwide | |
| CLASS II | Quantum 2000 Electrosurgical Generators Cooper Surgical recalled | CooperSurgical | Device Malfunction | Nationwide | |
| CLASS II | Leep Precision Generator 120V Cooper Surgical recalled | CooperSurgical | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | HSG Procedure Tray recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide |
| Device | CLASS II | Endosee System Convenience Kit recalled by CooperSurgical | CooperSurgical | Sterility | Nationwide |
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